www.fdanews.com/articles/206606-fda-grants-breakthrough-designation-to-datars-prostate-cancer-test
FDA Grants Breakthrough Designation to Datar’s Prostate Cancer Test
February 16, 2022
Datar Cancer Genetics’ TriNetra-Prostate blood test to detect early-stage prostate cancer has received the FDA’s Breakthrough Device designation.
The test can detect early-stage cancer with greater than 99 percent accuracy, without any false positives, the company said, helping clinicians to decide whether it is necessary to take a biopsy for a confirmatory diagnosis.
The Boston, Mass.-based company previously received the FDA’s Breakthrough Device designation for its early-stage breast cancer detection test.